MD Atlas
BlogPricingSign in
MD Atlas
Made In Tracker
Made In TrackerEasyUDI
Legal
Privacy PolicyLegal Notice
About
AboutFAQBlogPartnersContact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

  • MD Atlas
  • ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

Data from EUDAMED, last updated Jun 11, 2026

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

69520627J034LD

7 references

IVDR Class C
Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class C
Manufacturer
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

Device family identification

Device name
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)
Basic UDI-DI
69520627J034LD
Device model
Cassette
Issuing agency
GS1
Version date
Apr 9, 2025

Classification

Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class C
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
SRN
CN-MF-000018785
Country
China
Email
sales@dbluemedical.com

Authorised representative

Name
Mega Eurostar Sp. z o.o.
SRN
PL-AR-000042730
Country
Poland

Device characteristics

Self-testingAnimal tissues / cells

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • W0105099099Virology - rt & poc - other

References by status

Clinical investigations

Registered
No

Legacy certificates

Certificate number
EU-TDA-FI-20642-800030-2025-1
Type
refdata.certificate-ivdr-type.technical-documentation
Notified body
Sertio Oy (3018)
Validity
Apr 28, 2026 → Mar 21, 2030

References

7 references

Export results

Applied filters

  • basicUdiUlid·01JRC7F5WJTHDMMMVWME52E70K

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)CFRA1ST-5069520627740685On the market
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)CFRA1ST-100695206277405110On the market
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)CFRA1ST-150695206277404415On the market
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)CFRA1ST-250695206277402025On the market
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)CFRA1ST-2069520627740822On the market
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)CFRA1ST-200695206277403720On the market
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)CFRA1ST-3069520627740753On the market